Local Serious Adverse Event / Unanticipated Problem

A serious, unexpected and related or possibly related adverse event (SAE) is an event that has occurred to a research participant in a study under the jurisdiction of the Unity Health Toronto Research Ethics Board (REB) .

An unanticipated problem (UP) is any incident, experience, outcome that meets all the following criteria: unexpected in relation to the research and/or patient population and related or possibly related to participation in the research and points to increased risk/harm to the research participant.

All external serious adverse events or unanticipated problem must be reported to the REB within 7 days of the study team’s awareness of the event/report or within 3 days if fatal or life threatening.

  • Step 1: Complete the local SAE reporting form, with an original signature of the Site Investigator at the site where the SAE occurred.
  • Step 2: Provide three (3) hard copies of the completed form to the research ethics office, located at 250 Yonge St., 6th floor. One copy of the form will be date stamped and given back to you for your records. Incomplete submissions will be returned to the submitter.
  • Step 3: The submission will be reviewed by the REB.
  • Step 4: One copy of the form signed by the Chair or designee will be returned to the study team. 

Not sure if you need to submit a report to the REB? Use the quick reference tool for reporting SAEs / UPs

For more details, read the guidelines for reporting serious adverse events / unanticipated problems.